Senior Director, Pharmacovigilance Operations & Launch

Rezolute; United States; À distance; USD 255 000 - 315 000; Plein temps

Avantages offerts par ce poste

Health Insurance (Medical / Dental / V

Disability, Life & Long-Term Care

Holiday Pay

Tracking Free Vacation Program

401(k) Plan Match

Educational Assistance Benefit

Fitness Center Reimbursement

Résumé du poste

Rezolute is seeking a Director/Senior Director of Pharmacovigilance Operations to lead the safety function as the company advances a lead therapy toward regulatory approval and commercial launch.

The role covers strategy, risk management, signal detection, DSUR/PSUR oversight, and PV vendor governance, with cross-functional collaboration across Clinical Development, Regulatory, and Quality to ensure inspection-ready PV systems and processes.

Qualifications

• Advanced degree in health or life sciences; MD/PhD preferred.
• Significant pharmacovigilance leadership experience for late-stage programs.
• Experience supporting NDA/BLA submissions, product launch, or post-marketing PV.

Responsabilités

• Lead pharmacovigilance strategy across late-stage development, regulatory submissions, and post-marketing surveillance.
• Develop PV readiness for commercial launch including safety intake, case processing, and vendor interfaces.
• Oversee signal detection, risk assessment, DSURs/PSURs, and safety governance.
• Manage PV operations, vendor oversight, and ensure inspection readiness across clinical and commercial phases.
• Partner with Quality, Regulatory, Clinical Development, and Commercial teams on safety-related activities and lifecycle management.
• Build and scale PV capabilities and governance for a growing biotech company.

Connaissances

PV leadership

Late-stage development

Regulatory submissions

Vendor management

Formation

Advanced degree in life sciences

Outils

PV systems (Argus)

Description du poste

Rezolute is seeking a Director/Senior Director of Pharmacovigilance Operations to lead the safety function as the company advances a lead therapy toward regulatory approval and commercial launch.

The role covers strategy, risk management, signal detection, DSUR/PSUR oversight, and PV vendor governance, with cross-functional collaboration across Clinical Development, Regulatory, and Quality to ensure inspection-ready PV systems and processes.